RU2623991C2 - Percutaneous self-assembling module valve and methods for folding, assembling and delivering - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: module prosthetic valve assembly comprises a valve module and a self-assembling element each of which has a delivery configuration for being mounted in the delivery device. The valve module has a folded configuration for delivery, configured to be deployed for self-assembly and capable of being assembled into an operational configuration by means of the said self-assembly element. The self-assembly element has a configuration for delivery parallel to the longitudinal axis of the said delivery device, and in the folded delivery configuration, the valve module is flattened to a flat configuration. A method for folding the valve module of a modular valve delivery device in a skin delivery device is disclosed.

EFFECT: simplification of percutaneous implantation of the valve prosthesis.

5 cl, 10 dwg

Description

FIELD OF TECHNOLOGY

[001] The present invention relates to a multicomponent, or modular, prosthetic valve device — a prosthetic valve that can be delivered to the body unassembled and assembled — which is at least partially a self-assembled, self-assembled element and a method for assembling a modular valve device using a self-assembled item. The present invention also relates to a method for folding and delivering such a modular valve device and a method for assembling a device in a body using a self-assembly member. The modular nature of the valve device, the design of the valve module, and methods for folding the valve device provide a prosthetic valve introduced through the skin, which may have a smaller diameter upon delivery than the valve devices when fully assembled. The present invention also relates to a system that includes a self-assembled modular valve device and a reduced diameter delivery device compared to a delivery device for a fully assembled skin-inserted valve device.

BACKGROUND

[002] The human body has a large number of natural valves, including, for example, valves of the heart, esophagus and stomach, intestinal valves and valves in the lymphatic system. Natural valves can be destroyed for various reasons, such as diseases, aging, etc. The valve, in the operation of which there are violations, is not able to maintain the fluid flow in the body in one direction with a minimum pressure drop. An example of a valve that has abnormalities is a heart valve that is prone to stenosis, i.e. incomplete opening of valve flaps, or regurgitation, i.e. improperly closing the valve flaps. It is advisable to restore the function of the valve to restore the proper functioning of the organ with which the valve is connected. For example, the correct functioning of the valve in the heart ensures that the blood flows through the valve in one direction with minimal pressure reduction, which keeps the blood flow and blood pressure constant. Similarly, the proper functioning of the esophageal valve ensures that the secretion of acid in the stomach does not have a permanent irritating or damaging effect on the lining of the esophagus.

[003] Several prosthetic valve systems introduced through the skin have been described. One example described by Andersen et al. (Andersen et al., US Patent No. 5,411,552) includes an expandable stent and a compressible valve fixed to a stent prior to installation. The compressible valve may be a biological valve or a valve made of synthetic material. Andersen prosthetic valve is delivered and installed using a balloon catheter, the balloon of which is used to expand the prosthesis valve-stent to its final size. See also U.S. Patent No. 6,166,614 (Andersen, et al.) Entitled ʺValve Prosthesis for Implantation in the Bodyʺ and U.S. Patent No. 5840081 (Andersen, et al.) Called ystem System and Method for Implanting Cardiac Valvesʺ (истемSystem and method for implantation of heart valves.).

[004] Spencer et al. (Spenser et al., US Pat. No. 6,893,460) describe another prosthetic valve device comprising a valve structure made of a biological or synthetic material and a support structure such as a stent. The Spencer prosthetic valve is a valve assembly with flexible flaps, consisting of a tube having an inlet and an outlet and made of elastic material, configured to provide compressibility of the walls at the outlet. The valve assembly is attached to the supporting stent before installation. The valve device is assembled installed in a predetermined location inside the duct of the body, using installation tools such as a balloon catheter or similar device.

[005] Percutaneous implantation of prosthetic valves is safer, cheaper, and requires less time to recover a patient compared to conventional surgical procedures. However, the disadvantage of the known artificial prosthetic valves introduced through the skin is their large size, even after compression for delivery. The problem associated with such large sizes is that the diameter during the delivery of modern valve devices and the required diameter of the delivery systems, combined with the anatomical features of the parts of the body through which the devices must be delivered, can make lumen delivery problematic in terms of the likelihood of success, installation accuracy and the risk of complications. In particular, delivery complications may arise due to the shape of the lumen, for example, the significant natural curvature of the aortic arch and / or the sinuous iliac / femoral artery through which the catheter is inserted. In addition, catheters of this diameter tend to have less flexibility compared to catheters of smaller diameter, especially when introducing into them a large device that does not differ in flexibility; manipulating a catheter with such contents in a narrow blood vessel, especially in a curved blood vessel, significantly increases the possibility of damage to the wall of the blood vessel.

[006] The diameter upon delivery of the prosthetic valve introduced through the skin is partially dependent on the method by which the valve is folded. There is a need in the art for a prosthetic valve device that can be folded in a manner that minimizes the diameter of the device used for delivery, thereby minimizing complications and increasing the safety of valve replacement procedures. A device that can be placed in a vessel without additional damage to the wall of the lumen in the body is extremely necessary.

SUMMARY OF THE INVENTION

[007] The present invention relates to a self-assembled, multicomponent, or modular, valve device comprising a plurality of modules, which can be delivered through the skin in the form of separate or firmly connected modules, which in any case can be assembled in the body to obtain a functioning valve devices. The present invention provides valve modules that can take shapes different from their functional valve shapes, but are particularly preferred for delivering the modules to the assembly site. The present invention also relates to a method for assembling a modular valve device using a self-assembled element, a method of folding modules for delivery, a modular valve device containing modules folded in a manner that provides a minimum diameter for delivery, and a method for delivering a modular valve device containing folded modules and a self-assembled element . The self-assembly member facilitates module assembly, limiting the requirement for remote operation, and makes the valve replacement procedure more efficient.

[008] The modular prosthetic valve device comprises a self-assembly member and a plurality of modules for in vivo delivery and assembly. From a functional perspective, a plurality of modules may include a support structure and a valve module that are configured to be assembled in the body, for example, near the implantation site, at the implantation site, or at a location at some distance from the implantation site. The supporting structure provides the skeleton, or the bearing part, of the valve device, accommodating the valve module and holding it in a predetermined place inside the lumen in the body. The support structure can preferably expand to a working configuration and is delivered in a compressed state. The valve module comprises valve valve flaps and, when assembled into a working configuration, forms a tube having an inlet end and an outlet end. The valve module may itself comprise one or more modules, for example, an integral structure that can be inserted unassembled and folded, or a plurality of valve sections that can be inserted unassembled and folded. The design of the prosthetic modular valve device, whether the valve module is firmly connected to the support structure for delivery or not, allows the valve module to be folded in a manner that provides a minimum diameter of the prosthetic delivery device.

[009] The device modules can be inserted into the desired position into the lumen in a suitable delivery device, such as a catheter, and assembled in the body, for example, in the aorta, in the ventricle, or at the implantation site. After placing the modules from the delivery device inside the lumen, they can be assembled to obtain the valve device in a fully assembled form.

[0010] The self-assembly member is preferably attached to or passed through the valve module, thereby efficiently assembling the valve module from its unassembled configuration for delivery to its assembled operating configuration. According to some embodiments of the invention, the self-assembly member may further facilitate deployment of the valve module from its delivery configuration. According to some embodiments of the invention, a self-assembly member may attach the valve module to the support structure. According to other embodiments of the invention, a self-assembly member can firmly connect the valve module to the support structure during delivery. Like device modules, a self-assembled element can have a delivery configuration and a working configuration. The working configuration of the self-assembly member may be a predetermined configuration that provides the valve module with a functional shape. The configuration for delivery may be a configuration that facilitates its delivery through a narrow and winding vasculature. The self-assembly member may be actuated to return to a predetermined configuration from the configuration for delivery.

[0011] The system of the present invention includes a modular prosthetic valve device and a delivery device within which the device modules are folded so as to minimize the diameter of delivery to deliver the modules to the desired position in the body.

[0012] The present invention also relates to a method for folding a valve module for delivery. The valve module of the invention may be in an unassembled and deployed substantially planar configuration. From this unassembled, deployed configuration, the valve module can be folded in a way that cannot be applied to valve elements from preassembled skin-inserted valves used in the art. That is, the valve module can be folded unassembled by folding into a substantially cylindrical structure. For example, an unassembled valve module can be provided in the form of a single-layer structure that can be folded along one axis, for example, from the base to the top, in a folded configuration for delivery.

[0013] The present invention also relates to a method for delivering a modular valve device to a lumen in the body, optionally using a valve, and a method for assembling a modular valve device in the body. The method of delivering the device modules to the desired place for assembly in the body includes the transdermal introduction of the valve not entirely, but in parts (modules), folded or folded in the delivery device, and the use of an element with the effect of memory of the shape and possibly pushing rods or guide threads for deployment, placement and assembling the valve module after installing it from the delivery device.

[0014] The advantages that can be achieved using the present invention are that the proposed prosthetic valve system according to the invention allows to reduce the size of the valve for delivery compared with pre-assembled valve devices and, thereby, allows to increase the flexibility and reduce the diameter of the delivery device . The present invention may also facilitate assembly of a modular valve device since it requires less remote control. In addition, the described prosthetic valve device is minimally invasive, and the specified method of percutaneous delivery reduces traumatic damage and minimizes the complications arising from the procedure, thereby increasing the safety of the procedure and expanding the number of medical institutions equipped to carry out the replacement procedure valve skin.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In FIG. 1A and 1B show a valve module that includes 3 valve sections, unassembled (Fig. 1A) and assembled into a working configuration (Fig. 1B).

[0016] In FIG. 1C, 1C, and 1D illustrate methods for folding valve sections into a delivery configuration.

[0017] FIG. 2A-2C show a leaf substructure before folding and delivery (FIG. 2A), one method of folding a leaf substructure for delivery (FIG. 2B, configuration for delivery) and a leaf substructure, when unfolded and assembled using a self-assembled element into a valve component (FIG. 2A) . 2C, working configuration).

[0018] FIG. 3A-C show how it is possible to compress the leaflets in the form of a ring according to an embodiment of the invention (Fig. 3A) to an unassembled state (Fig. 3B, Fig. 3B ') and fold for delivery (Fig. 3C).

[0019] In FIG. 4A-B show two directions in which an assembled embodiment of the invention with ring-shaped flaps can be folded.

[0020] In FIG. 5A-5C show one embodiment of a self-assembly member for use with a valve module that includes a first self-assembly member and a second self-assembly member. In FIG. 5A schematically shows the first and second self-assembled elements in a predetermined configuration; In FIG. 5B schematically shows the first and second self-assembled elements in a configuration for delivery together with a folded, unassembled sash substructure; In FIG. 5C is a schematic illustration of an assembled valve module.

[0021] In FIG. 6A and 6B show one embodiment of a self-assembly member for a valve module that includes a first self-assembly member and commissural racks. In FIG. 6A is a schematic illustration of a self-assembly member in a predetermined configuration; In FIG. 6B is a schematic illustration of a self-assembly member in a configuration for delivery.

[0022] In FIG. 7 shows an embodiment of a modular valve device that includes a self-assembly member containing parts for attaching the valve module in an assembled form to the support structure.

[0023] In FIG. 8A-8B show how the valve module can be guided using threads or exhaust wires during assembly. In FIG. 8A shows guide threads attached to struts of a self-assembly embodiment of the invention shown in FIG. 6A; In FIG. 8B shows guide threads attached to articulation points of a valve modular embodiment of the invention shown in FIG. 7.

[0024] In FIG. 9 shows one embodiment of a self-assembly member comprising a ring foot for connecting the valve module and the support structure.

[0025] In FIG. 10 shows one embodiment of a self-assembly member that includes three racks with a shape memory effect that support the articulation points in the valve.

DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention provides a self-assembly modular prosthetic valve device comprising a self-assembly member and a method for assembling an implantable modular skin-inserted prosthetic valve device through the body of an implantable device. The invention proposes a self-assembly element that causes a change in the relative shape of the valve module of the modular valve device, in particular, causes a transition from an unassembled configuration to an assembled configuration. The self-assembly member may also provide means for assembling and / or connecting the valve module and the support structure. The assembled valve module can be folded in a manner that minimizes its diameter for delivery and, therefore, also minimizes the required diameter of the delivery device. The self-assembly member may also deploy the valve module from its configuration for delivery. Thus, the present invention also provides a modular valve device comprising a folded valve module, a method for folding a valve module for transdermal delivery, and a method for delivering a modular valve device, which includes transforming the valve module from its folded, unassembled configuration for delivery to its operational assembled configuration. A modular prosthetic valve device facilitates safe delivery into the body lumen without the need for invasive surgery.

[0027] The modular valve device according to the invention comprises a self-assembly member and a plurality of modules, such as a support structure and a valve module. The valve module may comprise a single module, i.e., a valve component, or it may comprise a plurality of modules, i.e., a plurality of valve sections that can be assembled to form a valve assembly. According to the invention, the device modules can be delivered one by one and assembled in the body using a self-assembled element. In particular, a self-assembly member may facilitate assembly of the valve module from a folded configuration for delivery to a three-dimensional operating configuration. Preferably, the self-assembled element can be attached to the valve modules unassembled or passed through them before folding for delivery and, thus, this element can contribute to both the deployment and assembly of the valve modules. In this application, it is understood that the phrase “attached to” includes “passed through” in the context of a self-assembled element attached to the valve module (assembled or unassembled), for example, along the base line or elsewhere on the valve module.

[0028] One embodiment of a valve module is a one-piece valve module that can be folded into a configuration for delivery and delivered separately from the support structure, and then deployed and assembled using a self-assembly member to form a valve component comprising a tube, ie, with obtaining a working configuration, followed by combining with the supporting structure. In one aspect of this embodiment, the integral valve module, which when unassembled, can be a leaf substructure containing a series of adjacent leafs that can be folded — for example, by folding along an axis — into a delivery configuration. In order to obtain the valve component in assembled form (i.e., in the working configuration), a series of leaves can be arranged in a three-dimensional structure, while the two ends of the leaf substructure meet and are connected. The self-assembled element can be attached to the wing substructure for assembly. The self-assembled element can assemble the leaf substructure into the valve component by returning to a predetermined configuration by moving the leaf substructure attached to it in such a way as to assemble it to obtain the valve component — in the assembled, working configuration — containing the tube.

[0029] In another aspect of this embodiment, the integral valve module in its unassembled state may be a sash ring (sash in the form of a ring), which is flattened to a two-layer, essentially flat configuration for folding, for example, folding along one axis, for example, from bottom to top, in a configuration for delivery. In this aspect of an embodiment of the invention, the self-assembled element may have a compressed configuration for delivery and may return to a predetermined configuration, which is a ring with a diameter corresponding to the ring-shaped casements to which it is attached to assemble the ring-shaped casements into an assembled, working configuration containing the tube.

[0030] According to another embodiment of the invention, the valve module is a one-piece valve module, like any aspect described above, which can be folded into a delivery configuration and deliver a sublight in a body firmly connected to the support structure, and not separately from it, and then deploy and assemble using a self-assembled element into the valve component containing the tube (working configuration) and assemble with the support structure to obtain the valve device fully assembled.

[0031] According to another embodiment of the invention, the valve module comprises a plurality of valve sections, which, in an unassembled configuration, can be folded separately or together in a configuration for delivery, and then deployed and assembled to form a valve assembly (operational configuration) using a self-assembly item. The valve sections can be partially connected using a self-assembled element that can be attached to each valve section. The valve assembly can be combined with the support structure to form the valve assembly. The self-assembly member can again return to a predetermined configuration by moving the valve sections attached to it in such a way as to assemble them to form a valve assembly.

[0032] The plurality of valve sections are so geometrical that they can fit together to form a valve assembly, the opening and closing of which, like the valve component described above, provides fluid flow in one direction and which functions exactly according to the physiological action normally functioning natural valve.

[0033] The modular valve device may, however, also comprise valve sections that are folded individually or together and then deployed and assembled to form a valve assembly using a self-assembly member and implanted in the absence of a support structure. Thus, according to this embodiment, the valve device includes a plurality of valve sections and a self-assembly member attached to each valve section, and thereby partially connecting the valve sections. The self-assembly member may function to arrange the valve sections to form the valve assembly in a manner similar to the method described above.

[0034] In the present application, the term “assembled” means that the valve assembly, valve component or valve device are in a working configuration (for example, they are essentially tubular rather than flat, compressed or separate modules), however, the modules are not necessarily bonded between by myself. In this way, the “unassembled” valve module can be difficult to deliver (configuration for delivery) or deployed and ready for assembly. The integral valve component “unassembled” may include a leaf substructure — a single-layer essentially flat structure having first and second ends, which can be assembled into a valve component (working configuration containing a tube) by arranging the first and second ends so that they meet and form ring. Alternatively, the integral valve component may comprise ring-shaped flaps which, when unassembled, are a two-layer substantially flat structure and which can open to form the valve component in an assembled state. Similarly, as described above, the “unassembled” valve assembly contains a plurality of valve sections that can be connected to each other in series and not in the form of a ring, for example, placed in a row to optimize folding of modules for delivery. Alternatively, the valve sections may not be interconnected and delivered separately. According to these and other embodiments of the valve module described herein, the unassembled configuration provides a geometric shape convenient for folding the valve component into a configuration for delivery with a small cross section.

[0035] The module (s) of the device, which are part of the valve module according to the invention, are offered in two configurations: unassembled and assembled. The unassembled configuration provides a particular advantage in the delivery of the valve module. Thanks to the unassembled configuration, the valve modules according to the invention can be folded into a delivery configuration, which minimizes the diameter of the valve modules during delivery. The assembled configuration can also be called a working configuration, in which the valve module is essentially tubular and forms a tube with flaps at a given location.

[0036] The self-assembly member may be a wire, tape, or strip, or a plurality of wires or tapes or strips. In the case of wire, the self-assembly member may have a round or rectangular (e.g., square) cross section. The self-assembly member has a delivery configuration that provides a small diameter cross-section for delivery and a predetermined configuration, which may be any predetermined shape suitable for assembling a valve module or valve device. The self-assembly element can be made of any various materials, such as, for example, an alloy with a shape memory effect, an alloy of cobalt and chromium, or a polymer deformable plastic. According to one embodiment of the invention, the self-assembled element comprises a metal or alloy with a shape memory effect, due to which it can return to a predefined configuration. In one aspect of this embodiment, the self-assembled member is an alloy wire with shape memory effect.

[0037] A predetermined configuration can be called a first configuration (eg, a relaxation state), and a delivery configuration can be called a second configuration (eg, a non-relaxation or restrained state). The self-assembled element can be actuated to return to a predetermined configuration by, for example, changing the temperature (heating or cooling), electric current, or freeing from the limitations associated with its geometric dimensions. According to some embodiments of the invention, the delivery device, or the rod or lumen in the delivery device, can hold the self-assembled element in the configuration for delivery, and the trigger mechanism may consist in removing this restriction. In this application, the “predetermined configuration” or the “first configuration” with respect to self-assembled elements is not limited to structures with the effect of shape memory. By “predefined configuration” and “first configuration” is meant a predetermined form that the self-assembled element takes or returns to when activated after installation from the delivery device. The shape memory alloy allows you to preassign the self-assembled element to a pre-selected shape (pre-set configuration) in a thermomechanical way, so that it can be entered, for example, in a relatively straight, but longitudinally flexible second configuration, and then activated to return to pre-set the specified configuration thermomechanically. The return of the self-assembled element with the effect of remembering the form to its first configuration can be initiated, for example, by means of a temperature jump or due to the release from geometric constraints. The temperature jump can be carried out by changing the ambient temperature around the self-assembly element, for example, under the influence of a hot liquid medium, cold liquid medium or body heat, or by passing an electric current through a wire with the generation of resistive heating. To obtain a self-assembled element with the effect of remembering the form, you can use any alloy with the effect of remembering the form. In particular embodiments, the shape memory alloy used is NiTi (e.g., nitinol), CuZnAl, CuAlNi, or a mixture thereof (See, e.g., SHAPE MEMORY MATERIALS, edited by Otsuka and Wayman, Cambridge University Press; October 1999 and SHAPE MEMORY ALLOYS, edited by Youyi and Otsuka, International Academic Publishers, June 1998).

[0038] The predetermined shape of the self-assembly member may be a shape compatible with the shape of the operating configuration of the valve module, for example a substantially circular, elliptical, lobular, or D-shape or other shape used to arrange, support, or bond one or more device modules . The self-assembled element may include axially oriented protruding elements (struts or supports) - that is, oriented along the longitudinal axis of the valve in a predetermined configuration - that can be used to assemble or connect the valve module and support structure to form the assembled valve device or which provide commissural support for the valve module. Alternatively, the self-assembly member may include a first and second self-assembly member. The second self-assembly member may include struts or supports that can interact with the support structure to engage the valve module and the support structure, or which can provide commissural support to the valve module. Thus, for example, according to one embodiment of the invention, the first self-assembly member in its predetermined configuration may be a ring for assembling the valve module in a rounded shape, and the second self-assembly member in its predetermined configuration may include axially oriented racks to support valve joints . Push rods can be used to position the self-assembly member and / or valve module and facilitate deployment and / or assembly of the valve module. Push rods can also be used to facilitate the placement of the valve module when combined with the support structure. According to some embodiments of the invention, the posts can serve as push rods or push rod extensions. According to one embodiment of the invention, the push rods may protrude from the proximal end of the delivery device, and the operator controls them from there. According to another embodiment of the invention, the push rods may be integrated into the delivery system. Alternatively, guiding threads or drawing wires can be used to adjust the position of the valve module during assembly and / or to facilitate the combination of the valve module and the support structure.

[0039] The valve module can be made from suitable materials, such as polymers, metals, or biological material, such as pericardium. The material, structure and manufacturing method are preferably selected in such a way as to facilitate the functioning, durability and biocompatibility of the valve.

[0040] The support structure can be made of a biocompatible material that is strong enough so that the structure can support the valve component or valve assembly while maintaining the position of the device within the lumen. The material of the support structure is also compatible with the delivery of the support structure in a compressed state and the expansion of the compressed support structure after placement in the lumen. According to one embodiment of the present invention, the support structure can be made of stainless steel or an alloy with a shape memory effect, such as, for example, nitinol. According to another embodiment of the invention, the support structure can be made of an amorphous metal of a suitable atomic composition. Other further embodiments of the invention of the support structure can be made from similar biocompatible materials known in the art. According to one embodiment of the invention, the support structure is ring-shaped, but it can also be provided in other forms, depending on the shape of the cross section of the lumen at the place where the valve is to be implanted. One non-limiting example of a suitable support structure is a stent. The support structure preferably has the ability to expand, so that it can be inserted in a compressed state (in an unexpanded state), and then deployed for implantation and assembly of the valve device. A stent, or any other supporting structure, can be, for example, self-expanding or expandable using a balloon. Other similar support structures are known in the art and can replace the stent according to this invention.

[0041] Further details regarding the structure, function and various applications of some embodiments of the modular valve device are set forth in §§ 37-47, 60-62, 65-82, and in FIG. 1-6 seconds in the pending application for US patent No. 12/686335 (modular), filed on the same date as this application, which is fully incorporated into this description by reference. For example, the proposed devices, systems and methods are particularly suitable for use in replacing aortic valve inserted through the skin, but may also find use in replacing other heart valves, such as, for example, pulmonary, mitral and tricuspid valves, as well as peripheral vascular system valves or valves located in other lumens of the body, including in the digestive tract, for example, the esophagus, lymphatic ducts, bile duct and in any other lumens containing valves, requiring e replacement, or needing valve implantation

[0042] The manner in which the valve device is folded affects the diameter of the prosthetic valve during delivery and the required diameter of the delivery device. The structure of the valve modules according to the invention allows them to be folded in a manner not accessible to known prosthetic valve devices inserted through the skin. As for the known prosthetic valve device introduced through the skin, its diameter during delivery is quite large and cannot be adjusted significantly by folding the valve in various ways. In contrast, the modular valve according to the present invention provides a valve module that can be folded into a delivery configuration from an unassembled configuration, i.e., it is not folded from a three-dimensional operating configuration. The valve module according to the present invention in an unassembled, expanded form can be placed in a substantially flat state (for example, "two-dimensional"), so that the valve flaps are arranged in a sequence or a continuous row for folding and, therefore, the valve module can be folded or folded from a substantially flat configuration to configuration for delivery, for example, from base to top.

[0043] In particular, the valve assembly in unassembled deployed form comprises a plurality of valve sections, with each section having a height (base-apex) generally directed along the longitudinal axis of the valve device in assembled form (and body clearance) —that is , in the axial direction, and a circular axis, which is generally directed around the circumference of the valve assembly. Similarly, the valve component in an unassembled, deployed form may comprise a leaf substructure having a generally rectangular or trapezoidal shape when placed substantially flat, which includes a series of adjacent flaps. The wing substructure has a length (or circular axis) —which includes the circular axis of each leaf, and the width (or height) extending between the base and the top of the row of leaves. The length of the wing substructure after assembly becomes the perimeter of the valve component (similar to the combined circular axes of the valve section of the valve assembly). Thus, according to any of these embodiments of the invention, the valve module can be folded unassembled in the direction of its height or in the direction of its circular axis without the need for further folding. It may be preferable to fold the valve modules in the direction of their height, that is, the base to the apex. The one-piece valve component, which is a pre-connected ring of flaps (ring-shaped flaps), when flattened to a substantially flat unassembled configuration, also has a length (or circular axis) and width (or height) and can be folded in the direction of its height. Folding the valve modules unassembled in this way, when combined with a separate compressed support structure, minimizes the diameter of the valve device for delivery.

[0044] The present invention also provides a method for delivering a modular valve device to a lumen in the body, if necessary, implanting a valve, and a method for assembling a modular valve device within a lumen.

[0045] A method for delivering a modular valve device includes delivering the device unassembled to a delivery device, such as a catheter. Two or more modules of the valve device can be provided by preloading the delivery device, such as a catheter or other similar device known in the art, or these modules can be loaded into the delivery device after the introduction of this device into the lumen of the body. The support structure and valve module (e.g., a leaf substructure or valve sections) can be loaded into the catheter one after another. Alternatively, first the support structure can be loaded into the catheter and delivered, then, for example, the valve sections can be loaded one after the other into the catheter and delivered to the support structure and the finished device assembled. The self-assembly member can be packaged together with a folded valve module and a compressed support structure for delivery in a delivery device. The methods described in this application allow the percutaneous delivery of an artificial prosthetic valve through a lumen with a smaller diameter than the diameter currently required for artificial skin valves introduced in the art through delivery of the valve device in the form of modules in unassembled and assembly of these modules in the body. According to alternative embodiments of the invention, a modular heart valve can be assembled in the left ventricle of the heart. According to other alternative embodiments of the invention, the modular valve device can be assembled in whole or in part in a delivery device. For example, the delivery device may include an assembly compartment, a part of the delivery device in which there is enough space to actuate the self-assembly member and assemble the valve module, or even combine the valve module and the support structure.

[0046] A method for assembling modules of a device includes actuating a self-assembly member attached to or passed through the modules to adopt a predetermined configuration that allows the modules to be assembled into a three-dimensional valve device (or valve module) and, according to some embodiments of the invention, of which the self-assembled element is not fastened together with the modules, the method also includes attaching the device modules to each other using fixing mechanisms. The self-assembly element allows the valve module to be assembled without the need for remote manipulation or minimizes the need for such manipulation. According to one embodiment of the invention, a second self-assembly member may be used to support valve joints. The second self-assembled element can be actuated to return it to a predetermined configuration, simultaneously with the first self-assembled element or separately from the first self-assembled element. According to another embodiment of the invention, the second self-assembled element can be used to combine the valve module and the support structure in the assembled valve device. According to another embodiment of the invention, the guiding threads or push rods can be used to control the assembly process. According to another embodiment of the invention, the exhaust wires can be used to facilitate the placement of the self-assembled valve assembly within the support structure and the assembly of the support structure and the valve module to produce the assembled valve device. Guiding threads can be controlled from the proximal end of the catheter.

[0047] The aforementioned embodiments of the invention, as well as other embodiments of the invention, delivery methods, various designs and various types of devices are described and explained below with reference to the accompanying drawings. It should be noted that the drawings are given as examples for understanding the present invention and schematically illustrate specific embodiments thereof. One of ordinary skill in the art will easily recognize other similar examples that are equally within the scope of the present invention. The drawings are not intended to limit the scope of the present invention defined in the attached claims.

[0048] According to one embodiment of the invention, a modular valve device may include four modules: three valve sections 150a-150c shown in FIG. 1A, and a support structure (not shown). The valve sections 150a-150c are adapted to fit together to form a valve assembly 115, as shown in FIG. 1B. In use, the valve assembly acts in much the same way as tissue folds in a natural valve. The valve sections, for example, 150a-c, which make up the valve assembly 115, can be folded for delivery in several ways. Various possible methods for folding valve sections are illustrated in FIG. 1C and 1C '(from one side to the other) and 1D (from the top to the base), which schematically show valve sections in the absence of a self-assembly element.

[0049] Each valve section has a vertical axis extending between the base and apex, and a circular axis (101), an axis extending across the width of the valve section. When combined, the circular axes of the valve sections are equal to the perimeter of the valve assembly. In FIG. 1C shows one way of folding three valve sections by folding along their vertical axes in the width direction (circular axes), which results in one folded valve module in an unassembled form (generally cylindrical in shape) with a diameter that includes all three folded sections valve, and a length equal to the height of the valve sections. According to an alternative embodiment of the invention illustrated in FIG. 1C ', the valve sections can be rolled individually along their vertical axes in the direction of their rotary axes 101, which results in three folded device components in an unassembled state (generally cylindrical in shape), each of which has a diameter smaller than the diameter which is achieved by the method shown in FIG. 1C. In FIG. 1D shows one way of folding the three valve sections by folding along their adjacent, parallel circular axes 101 in the direction of their height, from the base to the top, i.e., generally in the direction of the longitudinal axis of the valve, resulting in a folded valve module in an unassembled a view (generally cylindrical in shape) with a diameter of only one folded valve section that is smaller than the diameter shown in FIG. 1C, and a length equal to the sum of the widths (circular axes) of the valve sections, since all valve sections are fastened together, for example, using a self-assembly element. According to an alternative embodiment of the invention (not shown), the three valve sections can be rolled individually along their rotary axes 101 in the direction of their height, i.e., generally in the direction of the longitudinal axis of the valve, which results in three folded device modules in unassembled form (generally cylindrical in shape), with each module having the same diameter as in FIG. 1D. In FIG. 1D shows folding of the valve flaps from the base to the top, but, alternatively, the valve flaps can be folded from the top to the base to obtain a configuration for delivery.

[0050] In accordance with the present invention, in order to minimize the diameter of the valve assembly according to the invention, when folded for delivery - and thereby minimize the diameter of the delivery device, each of the modules of the valve assembly can be folded in the direction of their height, as shown in FIG. 1D. Then the valve sections can be delivered to the body one after the other, in the form of a chain of modules - one after another (interconnected) or separately - and then deploy and assemble. Valve sections folded in the direction of their rotary axis, as shown in FIG. 1C 'can also be introduced into the body one by one, in the form of a chain of modules, providing a minimized diameter for delivery, and then deploy and assemble. In FIG. 1C, 1C 'and 1D show how the three valve sections can be folded, however, the design of the prosthetic valve device according to the present invention makes it possible to obtain a valve assembly comprising less or more than three valve sections that must be folded in a similar manner in order to provide same minimized diameter for delivery. The diameter of the folded valve sections folded along the rotary axis in the direction of the vertical axis (as shown in Fig. 1D) or folded separately along the vertical axis in the direction of the rotary axis (as shown in Fig. 1C ') will be equal to the diameter of one folded leaf, regardless the number of flaps that the valve assembly contains.

[0051] A self-assembly member can be used to assemble valve sections 150a-150c to form valve assembly 115 according to the invention. The self-assembly member can be attached to a series of valve sections 150a-150c on the base line 102, on the vertical bond line of the joints 103 or on the base line and on the vertical bond line of the joints 102, 103 (shown by dashed lines in Fig. 1B), on the tip of the tip ( not shown) or at another point along the vertical (base-to-top) axis. The self-assembly member can be used to assemble valve sections 150a-150c to form valve assembly 115. It is possible that valve sections 150a-150c can be pre-joined and knitted using pull wires or threads (not shown) to bind together valve sections 150a-150c for delivery so that they can be introduced through the lumen of the body one after another. In normal use, a self-assembled element containing an alloy with a shape memory effect will assemble the valve sections rather quickly, as it again assumes its predetermined shape, which increases the assembly efficiency of the valve device.

[0052] FIG. 2A-2C depict yet another embodiment of a valve module: an integral valve module (valve component), which, when not assembled, may comprise a leaf substructure 200 that can be folded in a manner that minimizes diameter for delivery, i.e. its configuration for delivery. Before loading the casement substructure 200 into the delivery system, it can be deployed in an unfolded, unassembled, essentially flat and generally rectangular or trapezoidal shape having a vertical axis extending between the base and the apex (i.e., along the longitudinal axis of the valve device in assembled form ), and the rotary axis 201, as shown in FIG. 2A. The circular axis of the leaf substructure corresponds to the perimeter of the valve component in assembled form. Before loading into the delivery device, the sash substructure can be rolled along its circular axis, or from the base to the top, as shown in FIG. 2B, or from the top to the base, with the first and second ends 251, 252 of the leaf structure 200a forming the ends of the folded structure of the structure 200a. After installing a rolled or twisted leaf substructure from the delivery device, the leaf can be deployed to obtain a three-dimensional structure of the valve component, as shown in FIG. 2C using a self-assembly member according to the invention and / or using exhaust wires (not shown). The self-assembly member 230, which is a wire according to this embodiment, can be pre-installed to form a substantially circular shape by connecting the two ends 251, 252 of the sash substructure, as shown in FIG. 2C. According to the embodiment of the invention shown in FIG. 2A-2C, the leaflet substructure 200 comprises three leaflets 250a-250c, but the self-assembled element 230 can also be used when the leaflet substructure contains 2 or more leafs.

[0053] According to this embodiment of the invention, the self-assembly member 230 can be attached to the base line 202 of the sash substructure as shown in FIG. 2A to facilitate assembly of the valve component. However, according to other embodiments of the invention, the self-assembled element can be attached to the leaf substructure or passed through it on the vertical line of fastening of the joints 203 of the leaf substructure 200 and, according to still other variants of the invention, the self-assembled element can be attached both to the base line and to the vertical fastening lines of joints 202, 203 (in Fig. 2A, each line is depicted as a horizontal dashed line parallel to the circular axis), or on another circular line along the axis of the bases of a vertex, to facilitate assembly of the valve component by, for example, participate in the deployment valvular substructures 200 and forming the shape of the valve component. When the self-assembly member 230 is attached to the line of the base 202, and the leaf substructure 200 can be rolled along a circular axis from the base to the top, the self-assembly member 230 can be packaged in a folded leaf substructure 200, as shown in FIG. 2B. When the self-assembly member 230 is attached to the line of the base 202, and the leaf substructure 200 is folded along a circular axis from the top to the base, the self-assembly member 230 can be packaged along the folded leaf substructure 200a (as shown for another embodiment of the invention shown in Fig. 5B). When the folding substructure is folded along a vertical axis (not shown), the self-assembled member may have a delivery configuration other than a straight wire. The self-assembly member may be actuated to return to its predetermined configuration after installing the leaf substructure from the delivery devices. Fastening mechanisms can be used to attach the first end 251 to the second end 252 of the leaf substructure 200 after forming the three-dimensional valve module, as also described below.

[0054] Another embodiment of a one-piece valve module includes a ring of valve flaps (ring-shaped flaps), for example, similar to a flap substructure, but with ends connected during delivery — that is, a substantially tubular structure as shown in FIG. 3A-C. In FIG. 3A shows flaps in the form of a ring 310 in their installed state, i.e. in their three-dimensional working configuration, forming a tube. The self-assembly member 330 may be attached to the base of the flaps in the form of a ring 310. The self-assembled element 330 may have a predetermined first configuration similar in shape to mounted (assembled) flaps in the form of a ring 310. As shown in FIG. 3B and 3C, ring-shaped flaps may have an unassembled configuration and a folded configuration, respectively. Self-assembly member 330 can be pre-installed in the first configuration in a thermomechanical manner, but can be converted to a second configuration for folding and delivery of the valve module. Alternatively, the geometric dimensions of the self-assembly member 330 may be limited in a second configuration for delivery. According to this embodiment, the self-assembly member 330 includes two bending sections 335 having other properties than the rest of the self-assembly member, so that in their second configuration, these bending sections 335a form a bend, as shown in FIG. 3B ', therefore, the self-assembly member 330a in its configuration for delivery can be substantially linear. Another property of the bending portion 335 of the self-assembly member that provides bending may include, for example, the thickness of the material, the composition of the material, or when the self-assembly member is made of an alloy with a shape memory effect, which shape of the material is predefined thermomechanically. In FIG. 3B schematically shows annularly shaped leaflets 300 flattened to form a two-layer, substantially flat, unassembled configuration, and a self-assembly member 330a / 335a in its configuration for delivery. In FIG. 3B 'shows an enlarged view of the self-assembly member 330a and the folding portion of the self-assembly member 335a in their configuration for delivery. When the flaps in the form of a ring 300 are in their unassembled configuration, as shown in FIG. 3B and 3B ′, the self-assembly member 300 may be in a form that allows it to be folded into a configuration for low profile delivery. In FIG. 3C shows folded leaflets in the form of a ring 310a in cross section, folded along one circular axis in the direction of their vertical axis, from the top to the base (as indicated by arrows in FIG. 3B), to obtain a configuration for delivery with a small cross section. When folding leaflets in the form of a ring along a circular axis in the indicated direction, the self-assembled element 330a in its configuration for delivery is located on the outside of the obtained cylindrical shape during delivery. In its working configuration, after installation, the flaps in the form of a ring 310 can be combined with the supporting structure to obtain the valve device in assembled form.

[0055] The second self-assembly member may be used with the indicated embodiment of the invention and may include supports or struts or may be a second ring located in a different position on the valve component. Like the embodiments of the invention shown in FIG. 1C, 1C, 1D, and 2B, this embodiment also provides an advantage over pre-assembled (non-modular) prosthetic valve devices inserted through the skin because it provides a smaller diameter for delivery. In addition, the modified (unassembled) form of the valve component facilitates the folding or folding of the component by methods not known in the art.

[0056] According to this embodiment, the valve module can be folded into a configuration for delivery as follows: ring-shaped flaps can be folded along their circular axis in the direction of their height, from base to top or from top to base, to form a generally cylindrical forms. In FIG. 4A-B show two directions in which it is possible to fold an embodiment of a valve module with ring-shaped flaps unassembled 400. In FIG. 4A, ring-shaped flaps in an unassembled state 400, including a self-assembled element in a configuration for delivery (not shown), are folded along their rotary axis 401 from the base to the apex (the direction of folding is indicated by an arrow). In FIG. 4B, ring-shaped flaps in an unassembled state 400, including a self-assembled element in the configuration for delivery 430a, are folded along their circular axis 401 from the top to the base (the direction of folding is indicated by an arrow). Folded leafs in the form of a ring 400a, 300a can unfold under the action of a self-assembled element due to automatic return to its predetermined configuration or by the use of exhaust wires. In the latter embodiment, for example, one or more drawing wires can be attached to the apical portion of the leaflets, folded together with the leaflets in a configuration for delivery, and pulled to deploy the leaflets. Push rods can be used in combination with exhaust wires. According to this and other embodiments of the invention, the push rods may be, for example, rigid wires or tubular structures.

[0057] The skin valve devices known in the art cannot be folded as described above, because they are inserted in a pre-assembled form, or they are not designed so that they can be disassembled and re-folded by the proposed method. The valves of the valve devices used in the prior art, it is necessary to arrange the circumference, and not sequentially or in a row, as in the present invention and, therefore, it is impossible to fold the device to the diameter of one leaf. Moreover, pre-assembled prosthetic valve devices used in the art have a frame that does not bend, or otherwise increase the diameter for delivery of the device, since the valve element is bent and assembled inside the frame of the device before being inserted under the skin. Similarly, the methods for folding the valve module unassembled shown in FIG. 3C, 4A and 4B provide an advantage over the prosthetic valve devices introduced through the skin used in the art, since the embodiment of the valve module with ring-shaped flaps is designed for quick assembly from an unassembled shape, which allows it to be folded into a configuration for delivery with a small cross section.

[0058] An embodiment of a self-assembly member comprising a first self-assembly member and a second self-assembly member is shown in its predetermined configuration in FIG. 5A. In FIG. 5B-5C show how one can introduce such an embodiment of a self-assembled element together with a leaf substructure and use it to assemble a leaf substructure. As shown in FIG. 5A, the first self-assembly member 530 includes a main ring 531 and a strut 533, and the second self-assembly member 540 includes a portion of the base 542 that is in line with and attached to the first assembly and two struts 543a, 543b. According to this embodiment, the second self-assembled element 540 is connected by welding to the first self-assembled element 530, both elements can be made of an alloy with a shape memory effect, for example, nitinol. Other methods of connecting the first and second self-assembled elements are also applicable and are within the competence of a person skilled in the art. Alternatively, the first and second self-assembly elements may not be interconnected. Both in the delivery configuration and in the predetermined configuration, the struts 533, 543a and 543b are oriented in the longitudinal direction. In a predetermined configuration, the uprights 533, 543a and 543b are oriented parallel to each other and perpendicular to the ring 531 and part of the base, for example, extending distally from the ring 531 and part of the base 542, as shown in FIG. 5A, and when used, can provide commissural support to the material of the valve module. According to alternative embodiments of the invention, struts 533 may extend proximally. According to another alternative embodiment of the invention, struts 543a and 543b may extend proximally. According to a further alternative embodiment of the invention, the strut 543a may extend distally and the strut 543b may extend proximal. For a valve module containing three leaves, three posts can be used; fewer or more racks can be used with valve modules containing fewer or more shutters.

[0059] In the configurations for delivery, the first and second self-assembled elements 530a, 540 can be substantially straight, as shown in FIG. 5B. Alternatively, parts of the struts of the first and second self-assembled elements can be folded by folding back onto the ring and lower parts of the first and second self-assembled elements (not shown). According to both embodiments of the invention, at least the first self-assembled element can be attached to the base of the leaf substructure. The first and second self-assembly members 530a, 540 can be positioned outside the roll, which is a folded leaf structure 500a, as shown in FIG. 5B, or the folding substructure can be folded (rolled) around the first and second self-assembled elements (as shown for another embodiment of the self-assembled element shown in Fig. 2B). When the leaf substructure is deployed, the annular portion 531 of the first self-assembly member 530 can be returned to its predetermined configuration, thereby assembling the leaf substructure 500 so that the valve component 510 adopts a three-dimensional working configuration. A portion of the strut 533 of the first self-assembly member 530 and the strut 543a, 543b of the second self-assembly member 540 support articulated valve component assemblies 510, as shown very schematically in FIG. 5C to show how the valve component is assembled 510, and parts of the first and second self-assembled elements 531, 533, 543a, 543b located below. For valve modules containing fewer or more leaves, the first and second self-assembly elements 530, 540 can be provided with fewer or more parts of the struts, if necessary. A similar embodiment of a self-assembly member can be used in conjunction with valve sections to assemble the valve assembly.

[0060] An embodiment of a self-assembly member comprising a plurality of racks is shown in FIG. 6A and 6B. As shown in FIG. 6A, in its predetermined configuration, the self-assembly member 630 may comprise a ring 631 and a plurality of struts, according to this embodiment of the invention, three struts 633a, 633b, 633c designed for a valve module comprising three flaps. Racks 633a, 633b, 633c are oriented parallel to each other and in the longitudinal direction, and, in a predetermined configuration, perpendicular to the ring 631, passing in the distal direction relative to the ring 631, to support the valve joints. In FIG. 6B shows a self-assembly member 630 in a configuration for delivery. In particular, a portion of the ring 631 may be compressed in the shaft or lumen of the delivery device due to a geometric shape such as a spiral, as shown in FIG. 6B to achieve a configuration for small diameter delivery. After removing the constraint associated with the geometric dimensions, the self-assembly member 630 may return to its predetermined configuration, as shown in FIG. 6A.

[0061] The indicated embodiment of the self-assembly member 630 can be introduced by attaching it to the valve module as a self-assembly member for assembling the valve module, or it can be used as a second self-assembly member in combination with the valve module and the first self-assembly member, which is a simple ring , like the ring shown in FIG. 2A-C. When the annular self-assembled element with twisted uprights shown in FIG. 6A and 6B, is a second self-assembled element, it can be installed after placing the support structure and assembling the valve module in its working configuration using the first self-assembly element to provide commissural support to the valve module.

[0062] An embodiment of a modular valve device comprising a self-assembly member, which may also serve to hold the valve module and support structure together, is shown in FIG. 7. According to this embodiment, the self-assembly member includes an annular structure 731 that can return to a predetermined configuration collecting the valve module 705 and has a diameter large enough to engage a groove 729 on the ring attached to the support structure 720. Such a combination an annular structure 731 of a self-assembly member attached to the valve module 705, and an annular groove 729 of the support structure 720 provides a geometric clip for attaching the valve module 705 to the support structure Ur 720.

[0063] In FIG. 8A and 8B show how guiding threads 870 can be used to control a self-assembly member or valve module during assembly of the valve device. In particular, in FIG. 8A shows one embodiment of the guiding threads 870 attached to the uprights 633a, 633b, 633c of the embodiment of the invention of the self-assembly member 630 shown in FIG. 6A. Guide threads 670 can be used to control or control the release of ring 631 and struts 633a, 633b, 633c of self-assembly member 630. In addition, when self-assembly member 630 is a second self-assembly member, guide threads 870 can be used to guide ring 631 and stands 633a, 633b 633s per valve module for articulation support. In FIG. 8B depicts one embodiment of guide threads 870 attached to joints of a valve module, for example, valve module 705 shown in FIG. 7. According to the indicated embodiment of the invention, the guide threads 870 can apply ring release control during assembly of the valve module. Guide threads can also be used in combination with other embodiments of the valve device — for example, valve modules attached to a self-assembly member (s) in other configurations — for example, as shown in FIG. 5A-5B. According to an alternative embodiment of the invention (not shown), the push rods can be used in the same way as the guide threads, or in combination with the guide threads. For example, according to one embodiment of the invention, the guide threads can be passed through one or more pushing rods having a tubular structure, while the guide threads can be tensioned relative to one or more pushing rods. Alternatively, the guide threads can be controlled using mechanisms located in the delivery system.

[0064] The guide threads may have a proximal end that extends from the proximal end of the delivery device, so that the operator can control a self-assembly member or other structure attached to the distal end of the guide threads. Alternatively, guide threads may be integrated into the delivery device. Other arrangements of guide threads 870 with respect to the self-assembly member or valve module are within the scope of the present invention and can be easily recognized by a person skilled in the art from the description given in this application. A tube, referred to herein as a push rod, can be used to provide additional control over the orientation of the valve module (not shown) using the guiding threads 870 in a manner similar to that described for tubes used with exhaust wires, as described in §§ 74-76 and FIG. 4B-4C in U.S. Patent Application No. 12/686335 (modular), pending, filed on the same date as this application, which is incorporated herein by reference. In general terms, the tube can be drawn along the proximal end of the guide threads from the proximal end of the delivery device, moving forward towards the valve device, and used to further control the guide threads 870 and valve module 705. One or more tubes can be used in a similar way to control the guides strands 870 attached to struts 633a, 633b, 633c for additional control of ring 631 and struts 633a, 633b, 633c of self-assembly member 630, or guiding threads 870 attached in other places on the self-assembly element. Guide yarns 870 can be made from the same materials as drawing wires, for example metal, plastic or yarn, or they can be made from biodegradable material and left to decompose after use. Perhaps the guiding threads can be disconnected from the racks of the self-assembled element using electric current.

[0065] The self-assembly member 930 shown in FIG. 9 includes an annular structure 931 and a ring foot 934. In its predetermined configuration, the ring foot 934 is oriented in the longitudinal direction and perpendicular to the ring structure 931, extending proximally from the ring structure 931 towards the supporting structure (not shown for clarity). The ring tab 934 can be inserted into the tab groove 927 on the support structure (according to an embodiment of the invention shown here in a longitudinally oriented series of brackets placed along the inner surface of the support structure) either before loading the modules into the delivery device, or after installation from the devices delivery, either before or after the return of the self-assembly element 930 to its predetermined configuration and assembly of the valve module. An annular structure 931 can be attached unassembled to the valve module before folding and loading into the delivery device. This embodiment of the self-assembly element 930 not only allows the valve module and the supporting structure to be folded and compressed separately and delivered unassembled (to minimize the diameter for delivery) and to assemble the valve module using the ring structure 931, but also facilitates the assembly of the valve device from the valve module and the supporting structure due to the interaction of the foot of the ring 934 and the groove 927 for the foot. In an aspect of this embodiment, wherein the ring foot 934 is inserted into the foot groove 927 before delivery, the valve module and support structure can be firmly connected to each other during delivery; they are connected, but do not have the same spatial arrangement as in the working configuration and, therefore, remain modular (unassembled) and can be folded to obtain a configuration for delivery having a smaller diameter for delivery.

[0066] According to another embodiment of the invention shown in FIG. 10, the first self-assembly member includes an annular structure 1031, and the second self-assembly member includes struts 1045a-c, preferably attached to an annular structure (not shown) and oriented in a predetermined configuration perpendicular to the annular structure 1031 of the first self-assembly member, extending proximal from the annular structures 1031. In the configuration for delivery, the annular structure 1031 of the first precast element and the strut 1045a (and the ring) of the second self-assembly element can be straightened to facilitate folding with device modules and / or packaging in a delivery device. The annular structure 1031 of the first assembly element is preferably attached to the valve module and can be actuated so that it assumes its predetermined configuration separately from the struts 1045 of the second assembly assembly to assemble the valve module. By combining the valve module 1005 and the support structure 1020 to form the assembled valve device, the second self-assembly member can be actuated to return to its predetermined configuration 1045a, 1045b. Thus, the proximal end of the strut 1045 may return to a predetermined curved or twisted configuration to engage the support structure 1020, and the distal end of the strut 1045b may return to its predetermined configuration in which it deflects backward in the distal direction, like opening a folding cane. The distal end of the strut 1045b ends perpendicular to the annular structure 1031 of the first self-assembly member, but extends distally to support the valve joints.

[0067] According to any embodiment of the self-assembled elements, the self-assembled element can be attached to a leaf substructure, ring-shaped flaps or a plurality of valve sections for use in assembling a valve module and / or combining a valve module and a support structure in an assembled valve structure.

[0068] A method for delivering and assembling a modular prosthetic valve device using a self-assembly member can be illustrated with reference to an embodiment of a valve device comprising valve assembly 115 shown in FIG. 1. One embodiment of such a method, for example, can be implemented as follows: a delivery device, such as a catheter, bearing a support structure and a plurality of valve sections and a self-assembled element, can be inserted into the body lumen and promoted to the desired location in the body, for example, to the final the place where the valve device is to be implanted, or near it. The support structure can be installed first so that it can receive valve sections. After placing the support structure in the right place, you can install the valve sections from the delivery devices. After installation from the delivery device, the self-assembled element can be activated to return it to a predetermined configuration, thereby placing the valve sections in the form of a valve in assembled form. The valve sections can be assembled to form a valve assembly within the support structure, or they can be assembled outside the support structure and then placed therein. After the valve assembly is formed, the valve sections can be attached to each other using fastening mechanisms. If the valve assembly is formed outside the support structure, it can be placed in the support structure and combined with it, for example, by using drawing wires guiding the threads, as shown in FIG. 8A and 8B, or push rods. Then, the valve assembly and the support structure can be fastened together using fastening mechanisms, as described below. The use of self-assembled elements in a similar manner for the assembly and placement of a modular valve device comprising less than or more than four modules is fully within the scope of the present invention. If necessary, more than two self-assembly elements can be used to assemble the device modules.

[0069] A method for assembling a modular valve device comprising a leaf substructure using a simple self-assembly member as shown in FIG. 2A-2C can be implemented in a similar manner. Methods of assembling a modular valve device using one or more self-assembly members shown in FIG. 3A-B, 5-8, or other embodiments of self-assembly elements, may be implemented in a similar manner and are within the competence of those skilled in the art in light of the descriptions herein.

[0070] Draw wires (as described in detail in §§ 54, 65, 67-68, 71-76 and Fig. 4b-c in the pending application for US patent No. 12/686335 (modular), filed the same by the date as the present application, which is incorporated into this description by reference), are not required to assemble valve sections to obtain a valve assembly according to the invention, however, when using exhaust wires, they can be threaded through the valve assembly and support structure so that they are free tied them together upon delivery. Extraction wires can also be used to facilitate assembly of the valve assembly and support structure. The exhaust wires can be attached to the device modules using any suitable means known in the art, for example, passing wires through the hinges in each module, the connection of which can be easily disconnected by simply pulling at one end of the wire to remove the exhaust wires after implantation and fixing devices in the lumen of the body. The modules of the device may contain loops or small holes through which pull wires are drawn.

[0071] Suitable fastening mechanisms for fastening the first and second ends of the leaf substructure, for fastening the valve sections together and for attaching the valve module to the support structure are described in detail in §§ 48-51, 84-113 and FIG. 7-15 in the pending application No. 12/686335 (modular), filed on the same date as the present application, which is incorporated into this description by reference. In particular, such fastening mechanisms may include connecting components such as protrusion-cavity, hook mechanisms with slots, a locking mechanism with a curved groove (zipper); interference fit; push-fit connectors; snap mechanism; hook-with-eye components; hook with a beard; hook and groove components; mounting foot; bolt-notch type mount; and connecting or locking geometrical elements (for example, dovetail or studs, fingers, rivets or bolt-tube type connectors). The locking mechanism with a curved groove (zipper) can, in particular, be used to fasten the ends 251, 252 of the wing substructure 200 or the sides of the valve sections. The fastening mechanisms are preferably mechanisms of this kind that can easily engage from a remote location and also provide a reliable assembly that will not separate during use.

[0072] According to any one of the embodiments of the invention, it is possible and may be necessary to adjust the valve module to a support structure in order to ensure the exact final placement of the valve module. Therefore, for example, the valve assembly can be connected to the support structure in a controlled manner, which will provide final control of the position of the valve assembly relative to the support structure after implantation of the valve device. The mechanisms for adjusting the position of the valve module relative to the support structure are described in detail in §§ 21-24, 28-39 and in FIG. 1a-7 in pending US patent application No. 12/686340 entitled ʺ Method and Apparatus for Fine Adjustment of a Percutaneous Valve Structure ’, filed on the same date as this application and incorporated herein by reference. The support structure can also be controlledly connected to the vessel wall.

[0073] It is important that the prosthetic device is placed in the vessel (or in the lumen) with an accuracy that ensures proper valve function and patient safety. Accordingly, the apparatus and system according to the invention, as well as the assembly method of the apparatus, can be used in conjunction with the arrangement system and arrangement method of the modular apparatus described in §§ 22-42 and in FIG. 1a-2 in U.S. Patent Application No. 12/686337 (placement), pending подA System and Method for Placing a Percutaneous Valve Deviceʺ, filed on the same date as this application and incorporated herein by reference. As described in U.S. Patent Application No. 12/686337, which is undergoing simultaneous review, (placement), a method for locating a valve prosthetic device in a body lumen with increased accuracy includes, for example, securing a latch in the body lumen at a valve implant site; and using said latch to guide said prosthetic valve device to said valve implantation site. The latches may include a push-button or rivet-type device, hooks, a guiding suture thread inserted under the skin, connecting geometric elements, or any other type of docking device. According to some embodiments of the invention, the latch can be connected to a fastening wire.

[0074] It will be apparent to one of ordinary skill in the art that many variations, additions and modifications and other applications can be made with respect to the discovery that has been shown and described in detail in the present application using embodiments, without departing from the spirit or scope of the invention. Accordingly, it is understood that the scope of the invention as defined by the claims below includes all foreseeable variations, additions, modifications or applications.

Claims (7)

1. A modular prosthetic valve device comprising a valve module and a self-assembled element, each of which is installed in a delivery configuration for installation in a delivery device, the valve module having a folded delivery configuration configured to be deployed for self-assembly and to be assembled into a working configuration by means of said self-assembled element, wherein the self-assembled element has a configuration for delivery parallel to the longitudinal axis of said delivery device, and in a folded th configuration for delivery valve module is flattened to the flat configuration. 2. The device according to claim 1, in which the valve module in a flat configuration essentially extends in the same plane. 3. The device according to claim 1, in which the valve module is flattened to a two-layer configuration. 4. The device according to claim 1, in which the valve module is a leaf in the form of a ring. 5. The method of folding the valve module of a modular valve device for delivery in a device for delivery through the skin, according to which: providing a valve device comprising a valve module, which, when in a substantially planar configuration, has a first axis and a second axis; fold the valve module by flattening it to a flat configuration before loading it into the delivery device.

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